Specimen observation, collection, storage and preservation devices and methods of use

Abstract

The devices and methods taught in this disclosure are directed to facilitate the observation, collection, transportation, storage, and preservation of specimens possibly containing DNA, said specimens potentially constituting evidence of sexual assault. The devices and methods described further allow for a means of minimizing the possibility of specimen contamination, dilution, or degradation during the collection and storage processes. The disclosed devices may contain electrical components that provide for the generation and recordation of information (specifically, times, dates, and locations) related to circumstances surrounding the collection of such specimens. This information may serve as evidence corroborating the circumstance of specimen collection, it may help to maintain a known and identifiable Chain of Custody (CoC), and it may additionally be used for unique device identification (UDI), inventory control, and current procedural terminology (CPT) coding purposes.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Patent Application Ser. No. 61 / 818,070, filed May 1, 2013, which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present disclosure relates to devices for the observation, collection, storage, and preservation of specimens and the methods of their use. More precisely, the present disclosure relates to devices and the methods of their use for the observation, collection, storage, and preservation of specimens that may constitute evidence, including, but not limited to, biologic specimens that may contain deoxyribonucleic acid (DNA), and / or non-biological materials that may include chemical elements, including minerals and yet unknown particles. The disclosed devices and methods further provide for the incorporation of electrical circuits that may identify, record, and transmit information related to the device's use, for the purposes of corroborating s...

AI Technical Summary

Benefits of technology

[0014]The disclosed devices allow for storage of collected specimens in a manner that protects them from contamination, dilution, and / or degradation. Specimen integrity would thereby be best-maintained by crime scene analysts and / or laboratory personnel using proper packaging, handling, and storage methods in accordance with specimen collection and laboratory SOPs. These specimens could then potentially be available for later forensic or medical analysis, evidentiary use, etc.

[0017]The specimen-collection device may be configured as a roughly cylindrical sheath, inside of which one or more additional inner sheaths may be retained. Upon the actuation of an actuator, a portion or more of one or more of the inner sheaths may extend past the terminal end of the outer sheath in a telescoping fashion. An alternate method of actuating the actuator, or other further actuation of the actuator, may cause a specimen collector that is as of yet unexposed to the volume exterior to the most inner sheath to become exposed at the terminal end of the telescoped sheaths. The specimen collector should only be exposed when the terminal end of the telescoped most inner sheath is in proximity (proximity being considered a distance ranging from approximately fractions of an inch to approximately twelve inches) to the specimen collection site. After the specimen has been collected, but while the specimen collector is still in proximity to the specimen collection site, the actuator may be actuated in a reverse manner, causing the retraction of the specimen collector into the interior volume of the most inner sheath. By exposing the specimen collector only while in proximity to the specimen collection site, the user of the device may avoid possible contamination or dilution of the collected specimen during the placement of the device in proximity to the specimen collection site, or removal of the device from the specimen collection site. Once the specimen collector is retracted into the most inner sheath, the actuator may be further actuated in a reverse manner, causing the telescoping inner sheaths to be retracted into one another, and into the interior volume of the outer sheath. Once retracted, the device may be removed from the sample collection site without contaminating or diluting, the collected specimen during the device's withdrawal.

[0019]Having embodiments of the disclosed specimen-collection device available in a variety of sizes allows for increased comfort. Multiple sizes allow for an individual or their physician or health care provider to use the device with the most appropriate dimensions depending on the body cavity from which the specimen is to be collected and / or the individual's height, weight, number of vaginal deliveries, sexual experience, and / or other factors affecting comfort. An individual would be more likely to use a specimen-collection device configured for self-collection when empowered with multiple size choices for comfort and to avoid injury. Furthermore, a properly-sized specimen-collection device would reduce the likelihood of contamination of the specimen.

[0022]The security circuit may enable each specimen-collection device to be uniquely identifiable, and more specifically uniquely identifiable in a manner that comports to FDA UDI regulations. By enabling each individual specimen-collection device to be uniquely identified and monitored the security circuit may allow for CoC initiation and corroboration, while additionally facilitating inventory control, and CPT coding.

Problems solved by technology

Additionally, even if a victim of a sexual assault knows how to collect a specimen that may contain DNA, it is unlikely that they will have immediate access to tools for specimen collection and preservation at, or immediately following, the time of the assault.

Furthermore, devices currently employed in the art are not constructed for self-collection by the victim, but rather for use by a qualified, trained medical professional in a setting that has specialized exam tables and other apparatus.

This, combined with the awkward ergonomics of these devices in the self-collection context, make self-collection of such specimens difficult, if not impossible.

Frequently, a specimen becomes contaminated through the collection process itself, rendering that evidence of little to no use.

Contamination may obscure or obliterate a perpetrator's potential identification.

Specimens may become contaminated, diluted, or suffer degradation despite being collected in a timely and skillful manner if the specimen is not transported, handled, stored, and analyzed effectively.

During packaging, handling, transportation, handling, and / or storage, collected specimens may suffer contamination, dilution, or degradation, even if the collected specimens had been properly collected.

In court cases where DNA evidence is being introduced, improper or procedurally proper but ineffective methods of storing the DNA evidence may be introduced to challenge the validity of the evidence and / or the associated test results.

There are several ways that these can be challenged: a) the methods not being properly followed, b) the results not being properly applied, or c) the current method itself being ineffective.

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